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Femasys Receives FDA Clearance for FemChec Fallopian Tube Diagnostic

• Femasys Inc. has received FDA 510(k) clearance for FemChec, a diagnostic solution designed for checking the fallopian tubes using controlled contrast delivery. • FemChec is intended for use with an intrauterine catheter, delivering a consistent stream of saline and air for ultrasound evaluation of the fallopian tubes. • The device is a key component of Femasys' FemBloc non-surgical permanent birth control solution, confirming procedure success with natural contrast and ultrasound. • FemChec offers a safer alternative to traditional methods, reducing the need for radiology referrals, X-ray dye, and radiation exposure for women.

Femasys, Inc. (Nasdaq: FEMY) has secured FDA 510(k) clearance for its innovative diagnostic solution, FemChec, designed for assessing the fallopian tubes. This advancement promises a safer, more accessible method for women's health diagnostics. The clearance marks a significant step forward for Femasys in its mission to address unmet needs in women's healthcare.
FemChec is designed for the controlled delivery of contrast media to confirm tubal status during ultrasound evaluations. It employs a unique method, alternating between saline and air in a continuous stream, providing natural contrast during the procedure.

Key Benefits of FemChec

Kathy-Lee Sepsick, Femasys Founder and CEO, emphasized that "FemChec is an essential part of our suite of women’s health products, as it fortifies our position to provide safe and technologically-advanced diagnostic and therapeutic solutions addressing women’s healthcare needs." She added that FemChec is a key element of their FemBloc non-surgical permanent birth control solution, allowing for confirmation of procedure success by the same practitioner using natural contrast and ultrasound.
The traditional methodology often requires a referral to radiology, utilizes x-ray dye, and unnecessarily exposes women to radiation. FemChec aims to mitigate these risks by offering an in-office solution that relies on natural contrast and ultrasound technology.

FemChec's Role in FemBloc Trial

FemChec is integral to the ongoing FINALE pivotal trial for FemBloc, Femasys' non-surgical permanent birth control solution. The diagnostic tool is used to confirm the success of the FemBloc procedure, ensuring that the biopolymer implant effectively occludes the fallopian tubes.

About Femasys

Femasys is dedicated to addressing significant unmet needs in women's health through innovative therapeutic and diagnostic solutions. Their portfolio includes FemaSeed Intratubal Insemination, an FDA-cleared infertility treatment, and FemBloc, a non-surgical permanent birth control method in late-stage clinical development. The company's diagnostic products, such as FemVue and FemCerv, complement their therapeutic offerings, providing comprehensive solutions for women's healthcare needs.
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Highlighted Clinical Trials

Prospective Multi-Center Trial for FemBloc Permanent Birth Control

NCT05977751RecruitingNot Applicable
Femasys Inc.
Posted 10/31/2023

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Reference News

[1]
FDA clears Femasys' FemChec diagnostic device - MassDevice
massdevice.com · Sep 9, 2024

Femasys received FDA 510(k) clearance for its FemChec contrast-generating device to check fallopian tubal status. FemChe...

[2]
Femasys Inc. Receives U.S. FDA Clearance to Market FemChec®, an Innovative Diagnostic ...
finance.yahoo.com · Sep 9, 2024

Femasys Inc. receives FDA 510(k) clearance for FemChec, a diagnostic solution for fallopian tube status, integral to Fem...

[3]
FDA clears FemChec for fallopian tube occlusion testing - Medical Device Network
medicaldevice-network.com · Sep 9, 2024

Femasys received FDA clearance for FemCheck, a diagnostic device to test fallopian tube occlusion, used with FemBloc bir...

[4]
Femasys Inc. Receives U.S. FDA Clearance to Market FemChec®, an Innovative Diagnostic ...
biospace.com · Sep 9, 2024

Femasys receives FDA 510(k) clearance for FemChec, a diagnostic solution for fallopian tube assessment, integral to FemB...

[5]
Femasys Receives FDA Clearance for FemChec, Its Diagnostic Tool for Fallopian Tube Evaluation
femtechinsider.com · Sep 10, 2024

Femasys received FDA 510(k) clearance for FemChec, a diagnostic tool for fallopian tube status using ultrasound with con...

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